Author and deliver high‑quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions
Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness
Partner within cross‑functional, matrix teams to produce fit‑for‑purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements
Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs
Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well‑structured regulatory narratives
Review reporting and analysis plans, provide critical input on tables and data presentation, and apply efficient document development approaches, including review tools and automation

PhD or equivalent relevant experience within the life sciences
Advanced experience in clinical regulatory medical writing within the pharmaceutical industry
Demonstrated ability to independently author complex regulatory documents and lead or significantly contribute to CTD submission dossiers, including Module 2 documents
Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and interpretation of clinical data
Proven leadership capability with experience influencing and collaborating effectively in global, multicultural, and matrixed environments
Working knowledge of ICH guidelines, Good Clinical Practice (GCP), and strong written and verbal English communication skills

Principal Medical Writer

Key skills